CRC SOP 08f Administering studies and users in OpenClinica V1
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THIS SOP REMAINS THE PROPERTY OF THE UCT FACULTY OF HEALTH SCIENCES
University of Cape Town
Clinical Research Centre
Standard Operating Procedures
Title
Administering studies and users in OpenClinica
Number
08f
Version
1
Name
Title
Signature
Date
Reviewer
Authoriser
Effective date
Review date
1. Purpose
To provide instruction to the data manager and those UCT Information and Communication Technology Systems
(ICTS) staff members delegated responsibility by the Director of ICTS for administration of studies and users in the
OpenClinica application for a clinical study. The ICTS person(s) will be defined as holding the OpenClinica role of
Business/Technical Administrator (OpenClinica Administrator).
2. Scope
The Clinical Research Centre (CRC) will advise whether this document is mandatory for research where UCT’s
Faculty of Health Sciences (FHS) is the named sponsor or where CRC facilities are used (CRC SOP 02). This SOP
may, however, also be adapted for use for studies conducted by UCT clinical researchers where UCT is not the
sponsor.
3. Templates/forms
CRC 08f.1
Create/remove studies and users form
4. Glossary/definitions
None
5. Responsibilities and procedure
5.1. The OpenClinica Administrator will be the only person given permission to create new users, allocate
users already assigned to a study to a new study, edit user information, remove/restore a user.
5.2. The person delegated the responsibility of creating/removing a database in OpenClinica by the Principal
Investigator (PI) or sponsor will use a form CRC 08f.1 to request a new study or remove a study,
Printed copies of this SOP should be checked against the original version on the CRC website (www.crc.uct.ac.za)
CRC SOP 08f Administering studies and users in OpenClinica V1
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THIS SOP REMAINS THE PROPERTY OF THE UCT FACULTY OF HEALTH SCIENCES
providing details of the study and team members (including roles). This request will be submitted to the
OpenClinica Administrator:
5.2.1.Creating a new study. The OpenClinica Administrator will create a new study on request using the
“Create a study” task in the administration module of OpenClinica. The following information will be
obtained from CRC 08f.1:

Unique Protocol ID

Brief title

Principal Investigator name

Protocol type

Sponsor

OpenClinica study administrator
5.2.2.Removing a study. The OpenClinica Administrator will remove a study on request by clicking the
“Remove" icon in the Actions column of the Administer studies table in the administration module
of OpenClinica. The following information will be obtained from CRC 08f.1:

Unique protocol ID

Principal Investigator name
5.2.3.Creating/allocating users. The OpenClinica Administrator will create new users/delegate users
already assigned to an instance of OpenClinica to a new study, whether new or existing. The
following information will be obtained from CRC 08f.1:

User name

First name and last name

Email

Institutional affiliation

Active study

Role

User type
5.2.4. In the create a User Account module, the Administrator will select the User Password to be sent to
the user by email
5.3. Removing and restoring user functions
Printed copies of this SOP should be checked against the original version on the CRC website (www.crc.uct.ac.za)
CRC SOP 08f Administering studies and users in OpenClinica V1
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THIS SOP REMAINS THE PROPERTY OF THE UCT FACULTY OF HEALTH SCIENCES
5.3.1. Should a user need to be removed from a study so that they no longer have access, the OpenClinica
Administrator will remove the user by clicking the "Remove" icon in the main row of the Actions
column for that user in the Administration module
5.3.2.The following information will be obtained from CRC 08f.1:

User name

First name and last name

Active study

Role

User type
6. Document history:
Version No.
Date
Reviewer
Details of changes
Printed copies of this SOP should be checked against the original version on the CRC website (www.crc.uct.ac.za)